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Roflumilast · 1 trial · 1 indication
The Spatial Span test assesses the participant's working memory. During this task, participants are presented with a board containing blue blocks randomly arranged. The rater first taps out a pattern of blocks, beginning with two blocks and increasing with participant proficiency, and the participant is tasked with tapping the same pattern. After discontinuation of this part of the subtest, the participant is then tasked with tapping out the reverse pattern after the rater's demonstration. These patterns also begin with two blocks and increase with participant proficiency. The total score for this subtest ranges from 0 (worst) to 32 (best). A positive change from Baseline indicates improvement. Analysis of Variance (ANOVA) with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.
The HVLT assesses the participant's verbal learning. The test consists of a list of 12 words from three taxonomic categories which are presented orally, and the participant is asked to recall as many as possible after each of three learning trials. The key outcome variable for this task is the total correct responses in the three learning trials. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.
BOLD Functional magnetic resonance imaging (fMRI) changes in the blood-oxygen-level-dependent (BOLD) - signal, which changes in response to neural activity. Baseline fMRI measurements will be followed by rewarded delayed response Working Memory (WM) task measurements in which participants are required to remember the spatial location of a target stimulus (a dot) relative to a fixation cross. Participants are given feedback indicating success or failure. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect.
| Arm | Type | Description |
|---|---|---|
| Placebo + Roflumilast 100 μg + Roflumilast 250 μg | EXPERIMENTAL | Roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period. |
| Roflumilast 100 μg + Roflumilast 250 μg + Placebo | EXPERIMENTAL | Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period. |
| Roflumilast 250 μg + Placebo + Roflumilast 100 μg | EXPERIMENTAL | Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period. |
| Name | Type | Description |
|---|---|---|
| Roflumilast | DRUG | Roflumilast tablets |
| Placebo | DRUG | Roflumilast placebo-matching tablets |
| Second generation antipsychotic | DRUG | Second Generation Antipsychotic (SGA) medication for standard of care therapy will be sourced and managed locally by the site. |
Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. Meets schiz...
Roflumilast is an investigational small molecule being studied for use in schizophrenia. It was evaluated in a proof of mechanism study that combined roflumilast with antipsychotic medications in patients with schizophrenia. The study was a randomized, double-blind, controlled trial conducted in the United Kingdom.
Roflumilast is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company sponsored a Phase 1 proof of mechanism study of roflumilast in schizophrenia.
Roflumilast is in Phase 1 clinical development for schizophrenia. A single Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved for this use.
Roflumilast has one completed clinical trial for schizophrenia, registered as NCT02079844. The trial, titled 'Roflumilast Plus Antipsychotics Proof of Mechanism Study in Schizophrenia,' enrolled 20 participants in the United Kingdom and included adults aged 18 years and older.
Roflumilast is a distinct small molecule being investigated for schizophrenia. It was studied as an add-on to antipsychotic medications in a proof of mechanism trial. No alternative names for roflumilast have been reported in the context of this development program.